An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00250627
• Date of registration: 07/11/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
• Scientific title: An Eight-Week, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder
• Date of first enrolment: December 2004
• Target sample size: 465
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00250627
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, Chile, Croatia, Czech Republic, France, Germany, Mexico, Portugal, United States

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- 1.Male or female patients.

- 2.18 to 64 years of age.

- 3.Inpatients or outpatients.

- 4.Written informed consent from the patient and/or legally authorized representative.

- 5.Able to comply with the protocol and follow written and verbal instructions.

- 6.Subjects of childbearing potential must have a confirmed negative serum b-hCG test
prior to entry into Segment B and must employ an acceptable method of birth control
(e.g., oral, depot, or implanted contraceptive method, IUDs, sterilization, barrier
methods in conjunction with spermicide).

- 7.Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical
Manual of Mental Disorders, 4th edition, Text Revision criteria and confirmed by the
semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent
episode for at least one month prior to the entry.

- 8.Minimum total score of 22 on the Montgomery-Asberg Depression Rating Scale (MADRS).

Exclusion Criteria:

- 1.Patients whose current depressive episode is diagnosed with psychotic features,
catatonic features, seasonal pattern or post-partum onset.

- 2.The duration of the current depressive episode is greater than 2 years.

- 3.Patients who are currently suicidal or have a history of a suicide attempt within 3
years prior to entry.

- 4.Patients whose current depressive episode is secondary to a general medical
disorder.

- 5.Patients with a history or presence of bipolar disorders or psychotic disorders
according to the D and L criteria of the MINI.

- 6.Patients with alcohol dependence or abuse or substance dependence or abuse in the
past 12 months except nicotine or caffeine dependence.

- 7.Patients with a history of failure to respond to treatment with paroxetine or other
antidepressant medications.

- 8.Patients who have used the following prior to entry into Segment B: any
antipsychotic within 3 months,-fluoxetine within 35 days, -any monoamine oxidase
inhibitor within 21 days, any other antidepressant, anxiolytic, sedative-hypnotic, or
mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant
medications.

- 9.Females who are pregnant or breast-feeding.

- 10. evere or unstable cardiovascular, renal, hepatic, respiratory, hematological,
endocrinological, neurological, or other somatic disease that might interfere with
the evaluation of study medication.

- 11.History of seizures other than a single childhood febrile seizure.

- 12.ECG abnormalities of potential clinical significance including a QT interval with
Bazett's correction of 500 msec or more at entry.

- 13.Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.

- 14.Use of drugs with known risk for Torsade de Pointes within 7 days of entry into
Segment B.

- 15.Participation in a clinical trial of an experimental therapy within 30 days prior
to entry or prior participation in a clinical trial of saredutant.

- 16.Patients with a positive HbsAg or anti-HCV antibody test at screening.

- 17.Patients with any of the following at screening: ALT >2 times the upper limit of
the normal range (XULN), AST >2XULN, GGT >3XULN, total or conjugated bilirubin >ULN



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depressive Disorder

Intervention(s)

Drug: Saredutant succinate (SR48968C)

Primary Outcome(s)

The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Outcome(s)

The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.

Secondary ID(s)

EFC5573

Source(s) of Monetary Support

Please refer to primary and secondary sponsors